P.T. Meditrol

P.T. Meditrol specializes in quality control products for laboratory testing. Specifically, they produce controls like the Serum Ammonia Control and U-Trol Liquid Urine Dipstick Control. These products are used to verify the accuracy and consistency of diagnostic tests for ammonia levels in serum and urine dipstick assays, ensuring reliable test results in clinical settings.

P.T. Meditrol is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in markets governed by U.S. medical device standards.

P.T. Meditrol’s devices, such as the Serum Ammonia Control and U-Trol Liquid Urine Dipstick Control, are classified as Class I medical devices by the FDA. This classification applies to products posing minimal risk to users, typically those with low-to-moderate regulatory oversight. Class I devices are generally exempt from the 510(k) premarket notification process unless they fall under specific exemptions or require listing in the FDA’s database.

Yes, P.T. Meditrol’s devices are listed in the FDA 510(k) database. This registry tracks devices that have undergone the 510(k) premarket notification process (if applicable) or are required to be listed under FDA regulations. Listing ensures transparency about the device’s regulatory status and compliance history, though it does not imply approval—only that the device meets applicable requirements for its classification.